昆明山海棠汤剂及制剂治疗类风湿关节炎有效性及安全性Meta分析  

Efficacy and Safety of Tripterygium Hypoglaucum Decoction and Preparation in the Treatment of Rheumatoid Arthritis:A Meta-Analysis

作　　者：何凤霞[1] 黄樱华[1] HE Fengxia;HUANG Yinghua(The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine,Guangzhou,Guangdong,China 510405)

机构地区：[1]广州中医药大学第一附属医院,广东广州510405

出　　处：《中国药业》2022年第14期112-118,共7页China Pharmaceuticals

基　　金：广东省中医药局科研项目[20161133]。

摘　　要：目的评价昆明山海棠(TH)汤剂或制剂治疗类风湿关节炎(RA)的有效性及安全性。方法计算机检索中国知网(CNKI)、中国生物医学文献数据库(CBM)、中国学术期刊网络出版总库(CAJD)、维普数据库、万方数据库及PubMed、Embase、Cochrane等数据库,检索时限为各数据库自建库起至2021年9月。收集TH治疗RA的随机对照试验(RCT),采用Jadad评分原则评价纳入文献的质量,采用RevMan 5.4统计学软件进行Meta分析。结果共纳入14篇文献,15个RCT。Meta分析结果显示,TH组类风湿因子[MD=-24.39,95%CI(-34.82,-13.97),P<0.001],C反应蛋白[MD=-5.38,95%CI(-10.30,-0.46),P=0.03]水平及28处关节疾病活动度(DAS28)评分[MD=-0.24,95%CI(-0.45,-0.03),P=0.03]显著优于西药组;TH联合西药组总有效率[OR=3.16,95%CI(1.97,5.07),P<0.001],关节压痛计数[MD=-1.96,95%CI(-2.44,-1.48),P<0.001],肿胀关节数目[MD=-2.41,95%CI(-3.53,-1.29),P<0.001],DAS28评分[MD=-0.57,95%CI(-0.73,-0.41),P<0.001],晨僵时间[SMD=-0.56,95%CI(-0.72,-0.41),P<0.001],红细胞沉降率[MD=-6.21,95%CI(-8.22,-4.20),P<0.001]及C反应蛋白[MD=-2.85,95%CI(-3.59,-2.12),P<0.001],类风湿因子[MD=-32.84,95%CI(-53.24,-12.44),P=0.002]水平显著优于单用西药组。结论TH汤剂及制剂是治疗RA的有效药物,其联合西药的疗效明显优于单用西药。后期有待开展随机双盲、大样本、多中心联合、多指标的临床试验进一步验证。Objective To evaluate the efficacy and safety of Tripterygium hypoglaucum(TH)decoction or preparation in the treatment of rheumatoid arthritis(RA).Methods The randomized controlled trials(RCTs)of TH in the treatment RA in the CNKI,CBM,CAJD,VIP,WanFang,PubMed,Embase,Cochrane and other databases were searched and collected from the inception to September 2021.The Jadad scoring principle was used to evaluate the quality of literature included in the study.RevMan 5.4 statistical software was adopted for the Meta-analysis.Results Fourteen studies and fifteen RCTs were included.Meta-analysis showed that rheumatoid factor(MD=-24.39,95%CI(-34.82,-13.97),P<0.001],C-reactive protein[MD=-5.38,95%CI(-10.30,-0.46),P=0.03]level and Disease Activity Score-28(DAS28)scores[MD=-0.24,95%CI(-0.45,-0.03),P=0.03]in the TH group were significantly better than those in the Western medicine group,the total effective rate[OR=3.16,95%CI(1.97,5.07),P<0.001],tender joint count[MD=-1.96,95%CI(-2.44,-1.48),P<0.001],swollen joint count[MD=-2.41,95%CI(-3.53,-1.29),P<0.001],DAS28 score[MD=-0.57,95%CI(-0.73,-0.41),P<0.001],morning stiffness time[SMD=-0.56,95%CI(-0.72,-0.41),P<0.001),erythrocyte sedimentation rate[MD=-6.21,95%CI(-8.22,-4.20),P<0.001]and C-reactive protein[MD=-2.85,95%CI(-3.59,-2.12),P<0001],rheumatoid factor[MD=-32.84,95%CI(-53.24,-12.44),P=0.002]levels in the TH+Western medicine group were significantly better than those in the Western medicine group.Conclusion TH decoction and preparation are effective in the treatment of RA,and the efficacy of TH decoction combined with Western medicine is significantly better than that of Western medicine alone.However,the above conclusion needs to be further verified by randomized double-blind,large sample,multi-center joint and multi-index clinical trials.

关 键 词：昆明山海棠 类风湿关节炎 META分析 有效性 安全性 

分 类 号：R969.3[医药卫生—药理学] R976[医药卫生—药学]